NCT01108848已完成不适用
Patient Registry for Berinert®, a C1-Esterase Inhibitor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 318
- 试验地点
- 26
- 主要终点
- Incidence of thrombotic and thrombo-embolic events
研究概览
简要总结
The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient receiving CSL Behring's C1-esterase inhibitor
- •Written informed consent (may not be required for some retrospective chart review cases)
排除标准
- •Any patient participating in an HAE study using other C1-inhibitors than Berinert®
结局指标
主要结局
Incidence of thrombotic and thrombo-embolic events
时间窗: Within 30 days of treatment with Berinert®
Occurrence of suspected viral transmission
时间窗: Duration of the study, at least 3 years
Use of concomitant medications and plasma products
时间窗: Duration of the study, at least 3 years
次要结局
未报告次要终点
研究者
研究点 (26)
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